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EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility.
The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient.
The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect.
The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerecare compression garments | Device | all Cerecare compression garments |
| Measure | Description | Time Frame |
|---|---|---|
| Joint pain assessment | Assessment of the most painful joint by an VAS (Visual Analog Scale) [0-100mm]. The most painful joint at 0 months (= before use Compression Garments) will be choose as the primary outcome measure. The primary outcome measure will be done at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Joint pain assessment | Assessment of joint pain by an VAS (Visual Analog Scale) [0-100mm]: shoulder, elbow, wrist, finger, hip, knee, ankle. | 6, 12, 18 and 24 months |
| Daily monitoring of joint instability |
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Inclusion Criteria:
Exclusion Criteria:
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EDS patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Pontier | Clermont-Ferrand | 63100 | France | |||
| Dr Benistan |
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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Daily monitoring of joint instability as sprain, dislocation and subluxation (shoulder, elbow, wrist, finger, hip, knee, ankle).
| 6, 12, 18 and 24 months |
| Neuropathic pain assessment | Assessment of neuropathic pain by the PAIN Detect questionnaire. The PAIN Detect questionnaire contains:
| 6, 12, 18 and 24 months |
| Proprioception disorders | Assessment of proprioception disorders by the Berg Balance Scale (BBS) [0-56]. The BBS contains 14 items; each item is scored from 0 to 4. | 6, 12, 18 and 24 months |
| Functional independence assessment | Assessment of functional independence by the Functional Independence Measure (FIM) [18-126]. The FIM contains 18 items; each item is scored from 1 (total assistance) to 7 (complete independence). | 6, 12, 18 and 24 months |
| Tiredness | Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7]. | 6, 12, 18 and 24 months |
| Patient's quality of life | Assessment of Life quality by the SF-12 questionnaire (Short Form questionnaire on quality of life with 12 items). | 6, 12, 18 and 24 months |
| Tolerance: incidence of Treatment-Emergent Adverse Events | By questioning the patient and by a medical exam, evaluation of adverse effect due to compression garments (Yes/ No): itch, edema, blister, redness, dermal ulceration. | 6, 12, 18 and 24 months |
| Compliance | By questioning the patient, estimate the number of hours of compression garments daily use. | 6, 12, 18 and 24 months |
| Garches |
| 92380 |
| France |
| Dr Michot | Paris | 75015 | France |
| Dr Enjalbert | Perpignan | France |
| SLB Pharma | Rennes | 35000 | France |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |